A study to see if multiple doses of REGN668 given by injections under the skin is effective, safe and how it acts in the body of adult patients with moderate-to-severe atopic dermatitis caused by allergic response.

Conditions: Atopic Dermatitis
MedDRA version: 15.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-003836-29-DE

Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1. Male or female, 18 years or older
2. Chronic Atopic dermatitis for at least 3 years
3. History of inadequate rsponse to a stable (> / = 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for Atopic dermatitis within 3 months before the screening visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Prior treatment with REGN668
2. Presence of certnain laboratory abnormalities at the screening visit
3. Treatment with an investigational drug within 8 weeks
4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
5. Certain treatments and medical procedures, underaken within a particular timeframe prior to the baseline visit, preclude eligibility for participation in the study
6. Known history of human immunodeficiency virus (HIV) infection
7. History of malignancy within 5 years before the baseline visit, with certain exceptions
8. Planned surgical procedure dirung the length of the patient's participation in this study
9. History of clinical parasite infection
10. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor’s medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
11. Pregnant or breast-feeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the clinical efficacy of repeated subcutaneous (SC) doses of REGN668 in adult patients with moderate-to-severe atopic dermatitis (AD).;Secondary Objective: Secondary objectives include:<br>• To assess the safety and tolerability of repeated SC doses of REGN668 in this patient population<br>• To assess the pharmacodynamics (PD) of repeated SC doses of REGN668 in this patient population<br>• To assess the relationship of AD skin severity, dermatology quality of life (QOL), skin barrier measures, and itch questionnaires to exploratory biomarker analysis;Primary end point(s): The primary endpoint is the percent change in Eczema Area and Severity Index (EASI) score from baseline to week 12.;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints include:<br>• Proportion of patients who achieve an Investigator’s Global Assessment (IGA) score of 0 or 1 at week 12<br>• Proportion of patients who achieve =50% overall improvement in EASI score from baseline to week 12 (achieving an EASI 50 [50% or greater improvement in EASI score]) is considered by dermatology investigators a clinically significant level of improvement to use as an endpoint.<br>• Change in EASI score from baseline to week 12<br>• Change (or percent change) in IGA score from baseline to week 12<br>• Change in % body surface area (BSA), SCORing Atopic Dermatitis (SCORAD) score, Pruritus numerical rating scale (NRS), 5-D Pruritus scale or Quality of Life Index for Atopic Dermatitis (QOLIAD) from baseline to week 12<br>• Incidence of treatment-emergent adverse events (TEAEs) from baseline through week 20;Timepoint(s) of evaluation of this end point: Throughout the duration of the study

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